No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 70
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for
This trial is looking for adults aged 40-70 with stage 3 chronic kidney disease. Participants will follow a specific diet and collect samples at home during the study.
Are You a Good Fit for This Trial?
Must not be takingMetforminInsulin
Rules you outHIV diseaseGastrointestinal diseaseCancer
You may be able to join if
I am aged 40-70 years
I have stage 3 chronic kidney disease
I am male or a postmenopausal female
I can follow a controlled diet for the study
I am willing to collect fecal samples at home
My kidney function is between 30-59ml/min
If my kidney function is 45ml/min or higher, I have albuminuria greater than 300mg/g
You may not be able to join if
I have had a hemoglobin A1c greater than 7% in the last six months
I have high blood pressure greater than 150/100 mmHg
I have a history of major gastrointestinal disease
I have been hospitalized in the last two months
I have had significant unintentional weight loss recently
I have cancer or received cancer treatment in the last year
I have a known food allergy affecting diet
I have a history of hyperkalemia
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this crossover clinical trial is to explore the effects of red meat intake on serum and fractional urinary excretion of uremic toxins including trimethylamine N-oxide in people with chronic kidney disease.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 40-70 years
* Male or postmenopausal female
* Stage 3 CKD (eGFR between 30-59ml/min/1.73m\^2 by the CKD-EPI equation (without race correction)).
* If eGFR is greater than or equal to 45ml/min/1.73m\^2 then albuminuria must be greater than 300mg/g creatinine by spot urine.
…
Inclusion Criteria:
* Age 40-70 years
* Male or postmenopausal female
* Stage 3 CKD (eGFR between 30-59ml/min/1.73m\^2 by the CKD-EPI equation (without race correction)).
* If eGFR is greater than or equal to 45ml/min/1.73m\^2 then albuminuria must be greater than 300mg/g creatinine by spot urine.
* Willing to consume controlled diet for duration of the study
* Willing to collect fecal samples at home
Exclusion Criteria:
* Hemoglobin A1c greater than 7% within previous six months
* Treatment with metformin or insulin within previous three months
* Blood pressure greater than 150/100 mmHg from chart of home on at least two occasions in prior month (can be inclusive of screening visit)
* Change in cardiovascular and/or hypertension medication in the last 30 days
* History of major gastrointestinal disease (e.g. inflammatory bowel disease, uncontrolled irritable bowel syndrome, C. difficile chronic infection, celiac disease, diverticulitis, stomach or duodenal ulcers)
* Known HIV disease
* Hospitalization in the last two months
* Significant recent unintentional weight loss (5% of weight over past three months)
* Cancer or received cancer treatment in the last year (except basal cell carcinoma)
* Prior bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band)
* Treatment with immunosuppressive medications in the past six months or more than one week of treatment with prednisone greater than 10mg per day in the past three months (or equivalent steroid dose of non-prednisone steroids)
* Recent antibiotic use defined as a single course of antibiotics within the past three months or two or more courses within the past six months
* Known food allergy that would influence the ability to consume the study diets
* History of hyperkalemia defined as greater than 5.5mmol/L on at least two occasions
* Other medical conditions or concerns at the discretion of the investigators
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